The Recall Desk

Hazard

Sterility Compromise recalls

2,228 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,228
Critical
3
Severe
255
Most recent
2026-08-19

Of the 2,228 sterility compromise recalls we have scored against our rubric, 3 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 255 (11%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterility compromise recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

851–875 of 2228

  • HighFDA (Devices)·Z-2015-2018·2018-06-06

    Arrow JACC IV Catheters Recalled Due to Potential Sterility Compromise

    Arrow International Inc. is recalling 416,055 ARROW JACC IV catheters because unsealed packaging may have compromised product sterility.

    Product
    ARROW JACC with Chlorag+ard Technology; Product Code: JR-42063-HPHNM and JR-42563-HPHNM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2030-2018·2018-06-06

    Arrow International Extension Line Slide Clamps Recalled for Sterility Concerns

    Arrow International is recalling Extension Line Slide Clamps because unsealed packaging may compromise product sterility. The recall affects 416,055 units distributed in the US and 34 other countries.

    Product
    Extension Line Slide Clamps; Product codes: SA-09847
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2002-2018·2018-06-06

    Arrow International Recalls Two-Lumen Central Venous Catheterization Kits

    Arrow International is recalling 416,055 two-lumen central venous catheterization kits because unsealed packaging may compromise product sterility.

    Product
    Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42802-DMC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1984-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Packaging Issues

    Arrow International is recalling 416,055 central venous catheterization kits because unsealed packaging may compromise product sterility.

    Product
    Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter and Sharps Safety Features; Product Code: ASK-24306-VC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2001-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Packaging Issues

    Arrow International is recalling 416,055 central venous catheterization kits because unsealed packaging may compromise product sterility.

    Product
    Double-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42802-VC and ASK-47702-VC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1994-2018·2018-06-06

    Arrow International Recalls Multi-Lumen CVC Kits Due to Packaging Issues

    Arrow International is recalling specific lots of ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kits because unsealed packaging may compromise sterility.

    Product
    ARROWg+ard Blue PLUS¿ Pressure Injectable Multi-Lumen CVC Kit; Product Codes: CDC-45703-P1A; CDC-45703-PB1A; CDC-42703-P1A; and CDC-15703-P1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1980-2018·2018-06-06

    Arrow International Recalls Multi-Lumen Central Venous Catheterization Kits

    Arrow International is recalling 416,055 Pressure Injectable Multi-Lumen Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PHMC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1988-2018·2018-06-06

    Arrow Multi-Lumen Central Venous Catheterization Kit Recalled for Packaging Defect

    Arrow International is recalling specific lots of ARROWg+ard Blue PLUS catheterization kits because unsealed packaging may compromise product sterility.

    Product
    Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Codes: ASK-42703-PAM1, ASK-42703-PSHR1, ASK-45703-PNY, ASK-45703-PWHC1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2020-2018·2018-06-06

    Arrow International Recalls PICC Catheter Trimmers Due to Packaging Defects

    Arrow International is recalling 416,055 PICC Catheter Trimmers because unsealed packaging may compromise product sterility. The recall covers units distributed in the US and 34 other countries.

    Product
    PICC Catheter Trimmer ; Product Code:PC-00001-T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1958-2018·2018-06-06

    Arrow International Recalls Continuous Nerve Block Needles Due to Packaging Defect

    Arrow International is recalling 416,055 continuous nerve block needles because unsealed packaging may compromise product sterility.

    Product
    Continuous Nerve Block Needle; Product Codes: AB-00090, AB-00150, AB-17040-N, AB-17080-N, AB-17110-N, AB-17140-N, AB-18080-N, AB-18110-N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2011-2018·2018-06-06

    Arrow International Recalls Spring-Wire Guide Introducer Catheter Assemblies

    Arrow International Inc is recalling 416,055 Spring-Wire Guide Introducer Catheter Assemblies because the packaging may be unsealed, potentially compromising product sterility.

    Product
    Spring-Wire Guide Introducer Catheter Assembly; Product Code: CN-04018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1989-2018·2018-06-06

    Arrow International Recalls Pressure Injectable CVC Kits Due to Sterility Concerns

    Arrow International is recalling 416,055 ARROWg+ard Blue PLUS Pressure Injectable Quad-Lumen CVC Kits because unsealed packaging may compromise product sterility.

    Product
    ARROWg+ard Blue PLUS¿ Pressure Injectable Quad-Lumen CVC Kit; Product Codes: CDC-42854-P1A and CDC-45854-P1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1973-2018·2018-06-06

    Arrow Radial Artery Catheterization Kit Recalled for Packaging Defect

    Arrow International is recalling Radial Artery Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04120-HF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1974-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Packaging Defect

    Arrow International is recalling 416,055 Single-Lumen Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Codes: ASK-04301-TJ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1931-2018·2018-06-06

    Medline Sterile Needle Counter Recall Due to Packaging Seal Creep

    Medline is recalling sterile needle counters because packaging seal creep may compromise sterility. The product is used to count surgical sharps.

    Product
    MEDLINE Sterile* Needle Counter, 100Ct. Double Magnet / Foam Block, reorder: DYNJNC100F Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1985-2018·2018-06-06

    Arrow Central Venous Catheterization Kit Recalled for Unsealed Packaging

    Arrow International Inc. is recalling ARROWg+ard Blue Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    ARROWg+ard Blue(R) Central Venous Catheterization Kit; Product Code: ASK-24306-WHC1 and ASK-24306-WHC2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1962-2018·2018-06-06

    Arrow International Recalls SnapLock Catheter/Syringe Adapters Due to Packaging Defect

    Arrow International is recalling SnapLock Catheter/Syringe Adapters because unsealed packaging may compromise sterility. The recall affects 416,055 units distributed in the US and 34 other countries.

    Product
    SnapLock" Catheter/Syringe Adapter; Product Code: AS-05500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2012-2018·2018-06-06

    Arrow TheraCath Epidural Catheters Recalled for Unsealed Packaging

    Arrow International is recalling TheraCath Epidural Catheters because unsealed packaging may compromise sterility. The recall covers 416,055 units distributed in the US and 33 other countries.

    Product
    TheraCath(R) Epidural Catheter; Product Code: EC-05000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2008-2018·2018-06-06

    Arrow International Recalls Catheter Clamps Due to Sterility Risk

    Arrow International Inc is recalling 7Fr. Catheter Clamps with Fastener because unsealed packaging may compromise product sterility.

    Product
    7Fr. Catheter Clamp with Fastener; Product Code: CC-00007
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1993-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Sterility Risk

    Arrow International Inc is recalling Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit; Product Code: ASK-42802-PWHC1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1975-2018·2018-06-06

    Arrow-Flex Percutaneous Sheath Introducer Kit Recalled for Packaging Defect

    Arrow International Inc. is recalling Arrow-Flex Percutaneous Sheath Introducer Kits because unsealed packaging may compromise product sterility.

    Product
    Arrow-Flex(R) Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath and Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters ; Product Codes: ASK-09903-UM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2005-2018·2018-06-06

    Arrow International Recalls Triple-Lumen CVC Kits Due to Packaging Defect

    Arrow International is recalling 416,055 ARROWgard Blue PLUS Triple-Lumen CVC Kits because unsealed packaging may compromise sterility.

    Product
    ARROWgard Blue PLUS Triple-Lumen CVC Kit with Blue FlexTip Catheter; Product Code: ASK-45703-VC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2006-2018·2018-06-06

    Arrow International Recalls Catheter Clamps Due to Sterility Risk

    Arrow International Inc is recalling 4Fr. Catheter Clamps with Fastener because unsealed packaging may compromise product sterility.

    Product
    4Fr. Catheter Clamp with Fastener; Product Code: CC-00004
    Category
    Medical Device
    Distribution
    Distributed nationwide